BPH
Conditions
Brief summary
This is a post-market study of a cleared biopsy system. The quality of tissue cores varies with standard of care biopsy needles. The SureCore Plus biopsy system is being evaluated as to quality and volume of tissue from prostate biopsy as compared to standard of care biopsy needles.
Detailed description
Biopsy sampling of the prostate using TRUS or TPPB guidance is the current SoC approach for diagnosis of prostate cancer (CaP). Over the past decades the number of samples required and considered adequate has risen from 6 to 12-18 and sometimes as many as 30. Many practices routinely sample up to 20 cores of tissue. The SureCore Plus biopsy system is being to sample, obtain and retrieve prostate biopsy specimens in men undergoing scheduled diagnostic prostate biopsy and compare it with an standard of care (SoC) biopsy instrument and SoC method of specimen retrieval.
Interventions
DEVICEEvaluation of two biopsy systems
Each subject will have prostate biopsy taken in 6 locations in one lobe of the prostate and then biopsy in 6 locations in the other lobe of the prostate
Sponsors
Uro-1 Medical
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Two-arm study of study biopsy needle and standard of care biopsy needle
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patient has BPH requiring a prostate biopsy * Able and willing to provide consent
Exclusion criteria
* Active infection * Subject participating in an other device study of the prostate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure success | During the procedure | \> 3 mm/cc of tissue collected in each biopsy |
| Quality of biopsy tissue | During the procedure | Ranking by pathologist on scale of 0=unable to read to 5=all tissue complete for reading. The higher scores mean a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance of the study device | During the procedure | Ranking by MD using scale of 1=difficult to use to 5=outperformed SOC needles. The higher scores equate to better outcome. |
Contacts
Primary ContactJeffrey Proctor, MD
Outcome results
None listed